Senior Principal Biostatistician

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $151k - $215k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Edwards Lifesciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1958

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Edwards Lifesciences is a global leader in patient-focused medical innovations. The company specializes in heart valve disease solutions, offering products and services such as transcatheter heart valves and mitral and tricuspid technologies, as well as surgical heart valve solutions. Edwards Lifesciences also focuses on critical care technologies including hemodynamic monitoring, remote monitoring, and predictive monitoring. The company conducts clinical research and is committed to improving patient lives through innovative cardiovascular disease solutions, while being a responsible corporate citizen with an emphasis on global corporate giving.

📋 Description

• Serve as statistical lead on multiple clinical trials • Coordinate analyses for study reports and other documents • Provide programming and validation support for clinical trial analyses • Collaborate with stakeholders to provide statistical expertise for new product development and regulatory submissions, including PMA, CE Mark, and PMDA • Represent Biostatistics on project and study teams • Communicate project and study status and timeline updates with management and team members • Research and recommend novel statistical methodologies and approaches • Provide guidance on ad hoc data analysis requests and publication/presentation efforts • Compile technical documents for internal and external audits • Improve, standardize, and globalize Biostatistics processes and procedures • Develop Biostatistics SOPs and Work Instruction Manuals • Lead data analysis efforts for data monitoring committees as needed • Mentor junior statisticians • Support resource allocation and budget/timeline development with management

🎯 Requirements

• Master's Degree or equivalent in Statistics, Biostatistics, or related field, with 7 years’ previous analytical experience in clinical trials • Ph.D. or equivalent in Statistics, Biostatistics, or related field, with 4 years’ experience • Proven expertise in R • Experience with additional statistical software packages (e.g., S-PLUS or other analytics tools) • Experience with CDISC standards, including SDTM and ADaM • Expertise in clinical trial data structures, data standardization, and regulatory-compliant statistical analysis • Ability to validate statistical outputs and review Tables, Listings, and Figures (TLFs) • Ability to develop TLF shells and contribute to study-related documentation • Proven expertise in MS Office Suite, including Word, PowerPoint, Access, and Excel • Excellent written and verbal communication and interpersonal relationship skills, including negotiation and relationship management • Ability to drive achievement of objectives • Knowledge of new developments in statistics and regulatory guidance • Expert knowledge of statistical methodologies related to clinical trial designs, statistical modeling, and data analyses • Expert knowledge of regulatory guidelines, including GCP, ICH, FDA, and ISO, relevant to pharmaceutical/medical device environments • Excellent problem-solving, organizational, analytical, and critical-thinking skills • Strong leadership skills and ability to influence change • Ability to provide training and coaching to lower-level employees • Experience facilitating change and collaborating with management and executive stakeholders

🏖️ Benefits

• Competitive salaries • Performance-based incentives • Wide variety of benefits programs for employees and their families